Association of high pre-pregnancy body mass index with adverse maternal and perinatal outcomes.

Background & Objectives: Obesity is an epidemic of the 21st century with its rates doubling in both developed and developing countries. It raises concerns for both maternal and fetal well-being and needs altered care throughout pregnancy and in postnatal period. Raised BMI prior to conception is associated with adverse feto-maternal outcomes. Limited data is available about its association with adverse maternofetal outcome in this region of the world. Our objective was to find out association of high pre-pregnancy BMI with adverse maternal and perinatal outcomes. Methods: This cohort study of 390 patients was conducted in Gynae department of Lady Reading Hospital Peshawar. Study duration was from June 2021 to March 2022. Patients enrolled in third trimester of gestation (≥ 37 weeks) were divided into two groups based on BMI i.e., Group-A with BMI <25 and Group-B with BMI ≥ 25. Both groups were followed until their delivery and discharge. Results: The mean age of 390 women was 28.2 ± 4.8 years. There was statistically significant association between raised pre pregnancy BMI and maternal risks like postpartum hemorrhage (p-0.0001), genital tract (p-0.0002) and perineal trauma (p-0.04). Neonatal risks significantly associated with high pre-pregnancy BMI were macrosomia (p-0.0001), and one minute APGAR score of < 8/10(p- 0.01). Both groups had no statistically significant difference for different modes of delivery i.e normal vaginal/ instrumental delivery and cesarean section (P-value 0.9). Conclusion: Maternal pre-conception BMI of ≥ 25 leads to poor maternal and perinatal outcomes.

Effect of Berberine Phytosome on reproductive, dermatologic, and metabolic characteristics in women with polycystic ovary syndrome: a controlled, randomized, multi-centric, open-label clinical trial.

Background: Berberine is a poorly absorbed natural alkaloid widely used as nutraceutical to counteract diarrhoea and to lower cholesterol and hyperglycaemia. It has also been reported to reduce signs and symptoms of polycystic ovary syndrome (PCOS). Objective: To explore, through a multi-centric, randomized, controlled and prospective study, the possible role played by a form berberine that is more easily absorbed (Berberine Phytosome®, BP) in 130 Pakistani women with a diagnosis of PCOS and fertility problems due to menstrual and ovary abnormalities. Results: Ninety days of supplementation with BP, administered at 550 mg x2/die, determined (i) resumption of regular menstruation in about 70% of women (versus 16% in the control group; p < 0.0001), (ii) normalization of the ovaries anatomy in more than 60% of women (versus 13% in the control group; p < 0.0001), (iii) acne improvement in 50% of women (versus 16% in the control group; p = 0.0409) and (iv) hirsutism reduction in 14% of women (versus 0% in the control group; p = 0.0152). The metabolic and the hormonal profiles of the women in the two groups did not significantly differentiate at the end of the study. BP was well-tolerated and no specific side-effects were registered. Respectively after one, two and 8 years of trying, three women supplemented with BP became and are currently pregnant. Conclusion: Our study showed the positive effects of BP supplementation in women with PCOS and confirmed the high safety profile of this nutraceutical. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT05480670.

A comparative absorption study of sucrosomial® orodispersible vitamin D3 supplementation vs. a reference chewable tablet and soft gel capsule vitamin D3 in improving circulatory 25(OH)D levels in healthy adults with vitamin D deficiency-Results from a prospective randomized clinical trial.

Background: Vitamin D (Vit D) deficiency (VDD), associated with diverse health conditions, is commonly treated with Vit D3 supplements. However, the gastrointestinal (GI) absorption of Vit D3 in different formulations has not been well studied. Objective: We aimed to compare the absorption of an innovative phospholipids-sucrester matrix biodelivery vehicle-based (sucrosomial®) orodispersible Vit D3 preparation against a reference chewable tablet and soft gel capsule (SGC) Vit D3 formulations in Vit D-deficient healthy adults. Methods: In study 1, 25 subjects were randomized to receive a weekly single dose of 200,000 IU of sucrosomial® Vit D3 (n = 12) or chewable tablet Vit D3 (n = 13) for 3 weeks. In study 2, 20 subjects were randomized to receive a single dose of 200,000 IU every other week of sucrosomial® Vit D3 (n = 10) or SGC Vit D3 (n = 10) for 6 weeks. Circulatory 25-hydroxyvitamin D3 [25(OH)D] levels were reassessed after 2, 3, and 6 weeks in study 1 and after 4 and 6 weeks in study 2. Results: In study 1, after 2 weeks, circulatory 25(OH)D levels increased significantly in both Vit D3 treatment groups (p < 0.0001) but improved markedly in the sucrosomial® Vit D3 group, with no further considerable change after 3 and 6 weeks in both groups. Overall, at all three follow-ups, sucrosomial® Vit D3 treatment achieved significantly higher and sustained 25(OH)D levels (p < 0.001). In study 2, after 4 weeks, both Vit D3 treatment groups showed significant improvement in circulatory 25(OH)D levels (p < 0.0001) but substantially higher in the sucrosomial® group with statistically significant differences between the two treatment groups (p = 0.02). At the 6-week follow-up, only subjects in the sucrosomial® Vit D3 group showed a further increase in circulatory 25(OH)D levels (p = 0.049), but no further significant changes in the levels of the SGC Vit D3 group (p = 0.062), showing a statistically significant difference between the two treatment groups (p = 0.002). The Vit D3 treatment was well tolerated by all participants, and no treatment-emergent effects or serious adverse events were reported. Conclusion: Our results suggest that the sucrosomial® Vit D3 preparation absorbs efficiently in the GI system, achieving adequately higher and sustained circulatory Vit D levels in VDD, and thus can effectively contribute to the body protection against VDD-associated health conditions. Clinical trial registration: clinicaltrials.gov, identifier: NCT05706259.

Caudal Duplication Syndrome in an Asymptomatic Primi Postnatal Patient.

Caudal duplication syndrome (CDS) is a rare congenital anomaly in which a wide spectrum of malformations ranging from partial or isolated to complete duplication of caudal organs in the gastrointestinal tract (GIT), genitourinary tract (GUT), and spinal and neural systems occur. Its exact cause is unknown, however various factors such as genetic disorders and conjoined twinning are mentioned in the etiology of CDS. Second-trimester anomaly scan can diagnose this anomaly prenatally. This case report describes a primi postnatal patient with CDS without any neurological symptoms. She gave birth to a healthy baby girl by cesarean section with breech presentation as an indication.